Safety and efficacy of subcutaneous (SC) administration of Clinimix N9G15E in elderly patients at risk for malnutrition, at a dose of 1 liter infused over 12 hours for 7 to 10 consecutive days. A prospective, multicentre, randomized, open-label, non-inferiority, controlled phase III B trial carried out in parallel groups: subcutaneous versus peripheral intravenous administration.

Baxter R and D Europe SCR0 sites120 target enrollmentMarch 11, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 11, 2008

End Date

April 9, 2010

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Baxter R and D Europe SCR

•1\. Both genders
•2\. Age superior or equal to 65 years
•3\. Hospitalized and at risk for malnutrition defined by their MNA SF below 12 and GNRI between 83\.5 and 97\.5\.
•4\. Oral intake \< 50% of appropriate intake (defined as 30 Kcal/kg/day) for an expected duration of greater than 3 days. Severe dehydrated patients must be rehydrated before enrolling into the trial
•5\. Dated and signed written informed consent, prior to any study\-related procedures, provided by the patient or, according to the law (L. 1122\-2\), by his legal representative or by a personne de confiance” if any written designation or, if not, his family member or, if no family member, a close relative
•6\. Patients in stable condition
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•1\. Malnutrition requiring tube feeding or parenteral nutrition when admitted to study. Parenteral nutrition includes use of glucose 10% or greater and amino acid solutions
•2\. Severe cardiac failure or serious cardiovascular compromise
•3\.Patients receiving therapeutic anticoagulation
•4\. Patients with coagulopathies (platelet count \< 100,000; Pt or PTT \> 1\.5 normal)
•5\. Severe burns or other diffuse skin diseases on site of the the infusion administration
•6\. Patient with decubitus ulcers greater than grade 2 (NPUAP classification)
•7\. Patient with an inflammatory syndrome defined by a CRP \>50 mg/L
•8\. Severe Renal failure
•9\. Known hypersensitivity to components of Clinimix N9G15E
•10\. Unconsciousness